Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
|
510(k) Number |
K113681 |
Device Name |
GLADIATOR PTA BALLOON DILATION CATHETER |
Applicant |
BOSTON SCIENTIFIC |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
AMBER JOHNSON |
Correspondent |
BOSTON SCIENTIFIC |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
AMBER JOHNSON |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/15/2011 |
Decision Date | 01/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|